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Drug ReportsMidazolam maleate
Versed, Buccolam(midazolam maleate)
Buccolam, Midazolam, Midozalam, Nayzilam, Seizalam (midazolam maleate) is a small molecule pharmaceutical. Midazolam maleate was first approved as Versed on 1985-12-20. It is used to treat anxiety disorders, psychomotor agitation, and status epilepticus in the USA. It has been approved in Europe to treat epilepsy.
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Clinical
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Target
Variants
Financial
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Events Timeline
5D
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3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
behavior and behavior mechanismsD001520
mental disordersD001523
Trade Name
FDA
EMA
Nayzilam, Seizalam (generic drugs available since 2000-06-20, discontinued: Midozalam, Versed)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Midazolam
Tradename
Company
Number
Date
Products
MIDAZOLAM IN 0.8% SODIUM CHLORIDEExela Pharma SciencesN-215868 RX2022-07-20
2 products, RLD, RS
MIDAZOLAM IN 0.9% SODIUM CHLORIDEInfoRLifeN-211844 RX2021-03-22
2 products, RLD, RS
NAYZILAMUCBN-211321 RX2019-05-17
1 products, RLD, RS
Midazolam hydrochloride
Tradename
Company
Number
Date
Products
SEIZALAMMeridian Medical TechnologiesN-209566 RX2018-09-14
1 products, RLD, RS
MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)Rafa LaboratoriesN-216359 PEND2022-08-08
1 products, RLD
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
midazolamANDA2024-07-15
midazolam hclunapproved drug other2016-04-06
midazolam hydrochlorideANDA2024-09-23
midazolam in sodium chlorideANDA2024-08-16
mkh dose packunapproved drug other2019-03-05
mko melt dose packunapproved drug other2019-03-04
n/aNew Drug Application2024-05-09
nayzilamNew Drug Application2023-01-19
seizalamNew Drug Application2023-01-26
versed guards up daily mineral sunscreen broad spectrum spf 35OTC monograph final2022-08-30
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Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration
Code
MIDAZOLAM, NAYZILAM, UCB INC
2026-05-17ODE-243
MIDAZOLAM HYDROCHLORIDE, SEIZALAM, MMT
2025-09-14ODE-207
Patent Expiration
Patent
Expires
Flag
FDA Information
Midazolam, Midazolam In 0.9% Sodium Chloride, Inforlife
109669902038-06-20DP
Midazolam, Nayzilam, Ucb Inc
82170332028-01-18DPU-2526
88093222028-01-18DP
92894322028-01-18DPU-2526
96874952028-01-18DPU-2526
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05C: Hypnotics and sedatives
— N05CD: Benzodiazepine derivative hypnotics and sedatives
— N05CD08: Midazolam
HCPCS
No data
Clinical
Clinical Trials
1498 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1791126189
AnesthesiaD000758——327192150
Postoperative painD010149—G89.18374152449
NeoplasmsD009369—C8034312846
DepressionD003863—F33.991587841
DeliriumD003693—R41.0413151740
AnxietyD001007EFO_0005230F41.1162131839
Depressive disorderD003866EFO_1002014F32.A81368737
PainD010146EFO_0003843R5273—101333
Anxiety disordersD001008EFO_0006788F41.1242101330
Show 268 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Status epilepticusD013226EFO_0008526G41129—415
Post-traumatic stress disordersD013313EFO_0001358F43.1—93—111
Traumatic stress disordersD040921———62—18
HypoxiaD000860HP_0012418R09.02——2—68
Heart arrestD006323EFO_0009492I46——2—57
AdenomaD000236————1—56
Renal insufficiencyD051437HP_0000083N193—3——6
SuicideD013405———31—15
Atrial fibrillationD001281EFO_0000275I48.0——1—45
SchizophreniaD012559EFO_0000692F204—1——5
Show 66 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A1962———7
Pulmonary tuberculosisD014397EFO_1000049A1542———5
Atopic dermatitisD003876EFO_0000274L2041———5
EczemaD004485HP_0000964L30.941———5
DermatitisD003872HP_0011123L30.941———5
Operative surgical proceduresD013514———2——24
Obsessive-compulsive disorderD009771EFO_0004242F4213——14
LeukemiaD007938—C9532———3
Myeloid leukemia acuteD015470—C92.032———3
Myeloid leukemiaD007951—C9232———3
Show 45 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug interactionsD004347——25———328
PsoriasisD011565EFO_0000676L4011————11
ArthritisD001168HP_0001369M05-M146———17
OverweightD050177—E66.36————6
Rheumatoid arthritisD001172EFO_0000685M06.96————6
Colorectal neoplasmsD015179——1———45
AmnesiaD000647EFO_1001454F44.03———25
MelanomaD008545——4————4
Sickle cell anemiaD000755EFO_0000697D573———14
Hepatitis cD006526—B19.24————4
Show 103 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Obstructive sleep apneaD020181EFO_0003918G47.33————55
AgingD000375GO_0007568R41.81————33
TachycardiaD013610HP_0001649R00.0————33
Cardiopulmonary bypassD002315——————33
Airway managementD058109——————33
Sleep wake disordersD012893—G47————33
Epidural analgesiaD015360——————22
Aortic dissectionD000784—I71.0————22
Thoracic surgical proceduresD019616——————22
Anterograde amnesiaD020324—R41.1————22
Show 169 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMidazolam maleate
INNmidazolam
Description
Midazolam is an imidazobenzodiazepine that is 4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted by a methyl, 2-fluorophenyl and chloro groups at positions 1, 6 and 8, respectively. It has a role as a GABAA receptor agonist, an anticonvulsant, an anxiolytic drug, an apoptosis inducer, an antineoplastic agent, a muscle relaxant, a sedative, a general anaesthetic and a central nervous system depressant. It is an organochlorine compound, an imidazobenzodiazepine and a member of monofluorobenzenes.
Classification
Small molecule
Drug classBenzodiazepine
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
Cc1ncc2n1-c1ccc(Cl)cc1C(c1ccccc1F)=NC2.O=C(O)/C=C\C(=O)O
Identifiers
PDB—
CAS-ID59467-70-8
RxCUI6960
ChEMBL IDCHEMBL2106922
ChEBI ID—
PubChem CID4192
DrugBankDB00683
UNII IDR60L0SM5BC (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 65,624 documents
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Safety
Black-box Warning
Black-box warning for: Midazolam, Midazolam hydrochloride, Midazolam in sodium chloride, N/a, Nayzilam, Seizalam
Adverse Events
Top Adverse Reactions
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13,912 adverse events reported
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